DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims priority to U.S. Provisional Application Number 63/287,857 filed 09/12/2021, and U.S. Provisional Application Number 63/329,674 filed 11/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/03/2023, and 08/28/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of claims
Claims 1, 11-12, 14-16, 19-21, 25-27, 31-32, 34-35, 63-64, 67-68 and 93 are pending in this application and are currently under examination. Claims 2-4, 10, 13, 17-18, 22-24, 28-30, 33, 36-38, 41, 45-48, 52-62, 66, and 69-92 are cancelled by applicant without prejudice or disclaimer. Claims 5-9, 39-40, 42-44, 49-51 and 65 are withdrawn.
Applicant’s arguments, filed 12/18/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract uses phrases ology which can be implied and is less than 50 words in length as currently written Described wherein are compounds that are inhibitors of wild type and oncogenic mutant c-KIT kinase and their use in the treatment of disorders such as cancers.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The lengthy specification (272 pgs.) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11-12, 14-16, 19-21, 25-27, 31-32, 34-35, 63-64 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 2736392-71-3. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2736392-71-3, Entered STN: 23 Nov 2021].
RN 2736392-71-3 anticipates the structural limitations of formula I of the instant claims where X1, X2 and X3 are CH, X4 is N, R1 is optionally substituted alkoxy, R2 is H, R3 is F, R4 is H, Q is
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67
95
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wherein s1 is the site covalently linked to the ring; and s2 is the site covalently linked to L wherein L is a C1-C6 alkyl, and E is optionally substituted non-aromatic heterocyclyl.
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503
785
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147
212
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Registry number: 2736392-71-3 is available as prior art as of 23 Nov 2021, the date it was indexed into the REGISTRY database.
See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public.
It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.
where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Allowable Subject Matter
The following is an examiner's statement of reasons for allowance: The compounds of claim 67 make a contribution over the prior art of record. The closest prior art to applicants compounds of claim 67 is tert-butyl (4-((5-fluoro-7-(2-methoxyethoxy)quinazolin-4-yl)amino) phenyl) carbamate, taught by Grecu (WO 2018/197642 Al). None of the teachings found in Grecu would fairly teach or fairly motivate a person having ordinary skill in art to formulate a compound as recited in claim 67. Since claim 93 depends from claim 67, claim 93 is also allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
Conclusion
Claim 67 is allowable, claims 1, 11-12, 14-16, 19-21, 25-27, 31-32, 34-35, 63-64, and 68 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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